| GC法检测布洛芬注射液中杂质F |
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| 引用本文： | 程开生,杨祥,臧洪梅. GC法检测布洛芬注射液中杂质F[J]. 安徽医药, 2014, 0(5): 823-825 |
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| 作者姓名： | 程开生 杨祥 臧洪梅 |
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| 作者单位： | 程开生(杭州锐思医药科技有限公司,浙江杭州,310052)；杨祥(杭州锐思医药科技有限公司,浙江杭州,310052)；臧洪梅(安徽医科大学药学院,安徽合肥,230032)； |
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| 基金项目： | 科技部中小企业创新基金课题(No,09C26223304082)；杭州市种子基金课题(项目编号：20090531K10) |
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| 摘 要： | 目的建立气相色谱法测定布洛芬注射液中的杂质F。方法采用气相色谱法,色谱柱：DB-WAXetr毛细管柱（25 m×0.53 mm×2μm）,载气为氦气,流速5.0 mL·min-1,检测器为火焰离子化检测器,检测器温度为250℃,进样温度为200℃。结果在选定的条件下布洛芬和杂质完全分离,杂质F的检测限为2.5 mg·L-1,检测方法的精密度、准确度、灵敏度均达到了预定的分析要求。结论建立的方法准确、灵敏,适用于检测布洛芬注射液中的杂质F。
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| 关 键 词： | 气相色谱法 布洛芬 杂质 |
Determination of impurity F in ibuprofen injection by gas chromatography |
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| Affiliation: | CHENG Kai-sheng, YANG Xiang(1. Hangzhou Raise Medical Technology Co. ,Ltd,Hangzhou Anhui Medical University , Hefei ,ZANG Hong-mei2 310052, China ;2. College of Pharmaceutics , 230032, China) |
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| Abstract: | Objective To establish a GC method to determine the impurity F in ibuprofen and its preparations. Methods The GC method was performed on a ZB-WAXetr capillary column（25 m × 0. 53 mm × 2 μm） and FID detector. The carrier gas was He with flow rate at 5 ml / min. The injector temperature and the detector temperature were 200℃ and 250℃,respectively. Results Under the described chromatographic condition,The impurity F was completely separated from ibuprofen. The LOD of impurity F was 2. 5 mg· L-1. Conclusions The analytical method is simple,accurate and sensitive with good reproducibility. It can be used to determine impurity F in ibuprofen and its preparations. |
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| Keywords: | gas chromatography ibuprofen impurity |
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